Medicine
Fluvastatin 20 mg capsule
Fluvastatin 20 mg capsule is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store and Dispense Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Fluvastatin
- Brand
- Sold under the generic name
- Strength
- 20 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 90 capsules, 30 capsules, 100 capsules and 2 more
- Manufacturers
- Mylan PharmaceuticalsTeva PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AA04 Fluvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 April 2012
- Identifiers
- RxCUI 310404, 310405DailyMed set ID aad8b373-0aec-4efb-8e61-3d8114b31127, d0a7247c-5d83-4bc1-840f-c58314d14195, f5e8d1da-8911-42db-9f90-cba04b28d011NDC 0093-7442, 0378-8020, 63629-8812Application ANDA078407, ANDA090595
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 capsule in 1 bottle, plastic | 0378-8020-77 | Mylan Pharmaceuticals | 11 April 2012 |
| 30 capsule in 1 bottle, plastic | 0378-8020-93 | Mylan Pharmaceuticals | 11 April 2012 |
| 100 capsule in 1 bottle | 0093-7442-01 | Teva Pharmaceuticals | 12 July 2012 |
| 30 capsule in 1 bottle | 0093-7442-56 | Teva Pharmaceuticals | 5 July 2012 |
| 100 capsule in 1 bottle | 63629-8812-1 | Bryant Ranch Prepack | 10 September 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 December 1993 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Fluvastatin
Clinical summary
Fluvastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease, among other approved uses. MedsAcross supplies Fluvastatin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FluvastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FLUVASTATIN SODIUM ER prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Fluvastatin 20 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.